Breast cancer is one of the health threats most feared by women, and is indeed the most common form of cancer in women. A key to treatment is early detection. For example, an annual mammogram is a method that has been used in hopes of early detection of breast cancer. One problem with mammography is that such an imaging technique can only find breast cancer once it has taken form. All too often, breast cancer is discovered at a stage that is too far advanced, when therapeutic options and survival rates are severely limited. While breast cancer is most common among women, in rare instances the human male may also have occurrences of breast cancer.
Other methods of detecting breast cancer are based on the fact that in a vast majority of instances breast cancer begins in the lining of mammary ducts. Studies have shown that fluid within the mammary duct contains high levels of breast cancer markers, and that an estimated 80%-90% of all breast cancers occur within the intraductal epithelium of the mammary glands. Fluid within the breast ducts contains an assemblage and concentration of hormones, growth factors and other potential markers comparable to those secreted by, or acting upon, the surrounding cells of the alveolar-ductal system. Likewise, mammary fluid typically contains cells and cellular debris or products that can also be used in cytological or immunological assays. As such, techniques such as ductal lavage, collection of mammary duct discharge, and brushing biopsies have been utilized to obtain such samples for diagnostic purposes.
In either event, once suspicious tissue is located, a biopsy of the tissue may then be taken. One biopsy device that has been utilized is the Mammotome® biopsy system available from Ethicon Endo-surgery, Inc., Cincinnati, Ohio. After mapping an area to be biopsied, the Mammotome® probe, a needle-like device with a hollow passage therethrough, is introduced through an incision cut into the breast and inserted with a sharpened distal end until the desired biopsy region is accessed. When the probe is positioned at the region of concern, tissue is received into a window in the probe with vacuum assist. A cutter then cuts and removes tissue samples for examination. The samples are passed through the hollow passage of the probe into a collection chamber. Because the Mammotome® probe is directional, multiple specimens can be collected without having to remove and reinsert the device. The Mammotome® probe is removed after the samples have been collected, and the incision is closed.
Such a system significantly decreases the invasiveness of the biopsy procedure by only requiring a small incision and puncture, which may be done under local anesthetic. However, in certain situations, such as where the tissue to be biopsied is in a mammary duct, the incision and probe insertion required with the Mammotome® is unnecessarily invasive and undesirable.
What is needed is a biopsy device for conducting a minimally invasive biopsy procedure without the need for an incision or anesthetic. It is also desirable that the physician be able to take multiple tissue samples from a single biopsy site. It is further desirable for the physician to be able to identify and record the location of each sample of tissue extracted. The present invention meets the foregoing desires and provides an improved device for taking a biopsy within a mammary duct, as well as a device that facilitates memorializing in the patient's records the location of the tissue sampled.